BR112020005968A2 - preclinical assessment of skin condition and risk assessment - Google Patents

Abstract

A system to quantify the risk associated with preclinical indicators of one or more clinical skin conditions, the system is formed by a plurality of measurement tools in connection with a processor, the measurement tools configured for various preclinical indicators of the skin health of an individual's hands, where the processor is configured to calculate a score based on the combined data from the plurality of measurement tools, this score being representative of the individual's risk of future development of one or more clinical skin conditions .

Description

Description of the Patent Invention “PRE-CLINICAL SKIN CONDITIONING AND RISK ASSESSMENT” Field of the invention

[001] The invention relates to a system of diagnostic tools. Particularly, but not exclusively, it refers to a system for the quantification of risk associated with pre-clinical indicators measured for one or more clinical skin conditions.

Fundamentals of the invention

[002] It is known that monitoring best hygiene practices reduces infection rates in healthcare environments. This monitoring can be carried out in real time or as a series of snap shots over time when trends can be determined. Such monitoring principles also apply to skin care, where monitoring the correct use of skin care products helps to recognize and prevent skin diseases.

This is particularly relevant in work environments where workers may be exposed to a number of different products that can affect a workers' skin condition. It is known that occupational dermatitis among workers can cause these workers to require time off work, and therefore it is desirable to be able to monitor the health and occupational condition of the skin.

[003] Skin disease and conditions associated with skin health, in particular, skin health of the hands, is undoubtedly the most common occupational disease, with occupational contact dermatitis (CD) being responsible for up to 95% of all occupational skin diseases; irritant contact dermatitis is responsible for most cases. Contact dermatitis can have a serious adverse impact on social and occupational aspects of life, including lost days at work, and threat to employment.

[004] In order to develop a better occupational skin care practice, it is necessary to assess the health of the skin, in order to recognize and control a multitude of skin diseases and link its prevalence with skin care practices. This has traditionally been difficult due to a reliance on self-reporting and underreporting associated with skin health.

[005] For this purpose, companies or facilities must carry out audits of the skin condition. Typically, these audits are carried out on a voluntary basis, and provide a measure of the health of a particular individual's skin. Such audits are largely performed visually and simply quantify the number and severity of the apparent symptoms of bad skin, providing a one-off score that is only applicable to that particular individual. In addition, current scoring methods tend to generate scores that group most results together due to the underlying data, which limits their usefulness in immediate action.

[006] An object of the present invention is to alleviate some of the deficiencies of the prior art mentioned above.

Declarations of the Invention

[007] According to one aspect of the invention, a system is provided to quantify the risk associated with preclinical indicators of one or more clinical skin conditions, the system comprising a plurality of measurement tools in connection with a processor, the measuring tools configured to measure at least two of erythema, scaling, papule density, vesicle density, infiltration, fissures, the level of surface hydration, the skin barrier function and the loss of transepidermal water in an individual, in which each of the plurality of measurement tools is configured to provide a first score characteristic of the individual's hand skin health, and in which the processor is configured to calculate a second marker based on the first combined values from the plurality of media measurement, the second score that represents the individual's risk of future development of one or more clinical skin conditions.

[008] Therefore, the present method encodes the combination of individual measurements into an overall value, usable as a hand-to-person skin health score and risk factor. By calculating a unique number that characterizes and summarizes the combined data from a variety of measurement tools, which measure a variety of skin health indicators, the present invention produces a concise and simple scaling of output that allows a user promptly monitor the health of your skin (in particular, the skin of your hands), and allow the diagnosis of early signs of latent skin diseases and building them into a risk factor. In addition, the standardization of the test procedure and the use of measurement tools produce reliable, reproducible and accurate results that can be validly compared with previous or subsequent scores. The ability to consistently identify the skin conditions of the hands and quantify the risk associated with it can help in identifying and mitigating any risk associated with the clinical conditions of the hands.

[009] The invention allows an early indication, and therefore the likelihood, of a person, or facility, that they suffer from a clinical skin condition such as occupational dermatitis. Such pre-clinical diagnosis provides an early indication of skin disease on the user's hands and allows both preventive and corrective measures to be taken and identified best practices.

[010] Optionally, the processor provides one or more of the first weighting scores a different weighting when calculating the second score. By weighting different combinations of the first scores, the second score can be adapted to measure a particular skin condition or set of skin conditions.

[011] Optionally, the system also comprises a plurality of individuals, in which the processor combines the second score of each individual for a third score representative of the plurality of individuals.

Combining individual assessment data from a group of individuals into a single score allows the health of the skin of a population's hands to be summarized and screened more easily.

[012] Optionally, the plurality of individuals is representative of a larger population in such a way that the third score can be mapped to the larger population.

[013] Optionally, the largest population is the total workforce in the private workplace. Thus an entire facility can be monitored for changes in hand skin health that could indicate a systemic skin health risk linked to distinct occupational risks specific to a particular facility. In addition, this provides a traceable facility or useful employer rating to monitor the baseline level of your employees' skin health, identify sudden changes, long-term trends and monitor the results of any treatments implemented on particular individuals, groups or facilities whole.

[014] Optionally, the plurality of measurement tools comprises one or more of a temperature sensor, humidity sensor, parallel and polarized transverse light chamber and a chromatic absorption sensor. This allows the claimed system to monitor the vast majority of physical attributes and symptoms that can indicate a variety of varying degree skin conditions. In addition, the provision of such instruments reduces the effects of user or operator bias that may otherwise be present when dependent on human interpretation of visual skin health indicators.

[015] Optionally, the system also comprises a memory in communication with the processor, where the memory is configured to store data from multiple measurement sessions, and where the memory is still configured to provide data from sessions from previous measurements for the processor, and where the processor is configured to track changes in a score over time.

[016] Optionally, the processor is further configured to recognize a trend in measurement and historical data to predict future values of a score.

[017] Optionally, the system also includes means of indicating to warn a user that a calculated score exceeds a predetermined limit.

[018] Therefore, this provides an early warning capability for both individuals, groups of individuals and facilities with their associated populations. As such, an appropriate response can be triggered, the particular response depending on the limit that has been exceeded, as well as the particular skin health measures that contribute to the score.

[019] Other aspects of the invention will be evident from the set of claims attached.

Brief description of the drawings

[020] The Modalities of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

[021] Figure 1 is a schematic diagram according to an embodiment of the invention; and

[022] Figure 2 is a flow chart of a method according to an embodiment of the invention.

Detailed description of a modality

[023] In order to provide a system capable of quantifying the risk associated with preclinical indicators of one or more clinical skin conditions, a system 10 according to the present invention is provided.

[024] Figure 1 shows a schematic diagram of a system 10. System 10 comprises at least one processor 20, memory 30 and a measurement tool 40.

[025] The measuring tool 40 is a known measuring instrument configured to measure at least two of erythema, scaling, papule density, vesicle density, infiltration, fissure, the hydration level of the surface, the barrier function of the skin and the loss of transepidermal water of an individual. In one embodiment, the measuring tool 40 is provided by a plurality of separate devices 40, 50. In an alternative embodiment, the measuring tool 40 is a single, multi-function device. Therefore, in one embodiment, the measuring tool 40, 50 is one or more of a temperature sensor, humidity sensor, parallel or transverse polarized light chamber and a chromatic absorption sensor.

[026] Processor 20 is configured to receive data from measurement tool 40, 50. In one embodiment, this data is unprocessed measurement data.

In an alternative embodiment, these data are in the form of a scoring characteristic of a skin health component of the test subject's hands. From this data the processor 20 is configured to calculate a user score based on the combined data or first scores from the plurality of measurement tools, the user score representing the individual's risk of future development of one or more clinical conditions of the skin.

[027] System 10 further comprises a form of memory 30, preferably non-volatile memory, and processor 20 is configured to write data, such as scores calculated for memory 30. In one embodiment, memory 30 is local . In an alternative embodiment, memory 30 is an external database.

[028] In one embodiment, the system 10 comprises input means 70. Input means 70 in the embodiment is a means of activating, in a preferred embodiment, one or more buttons. In other ways, the user input means is an alphanumeric keyboard, with which the user can enter one or more commands. As such, any suitable known means can be used to allow a user to enter a command for system 10. These input means 70 are known in the art.

[029] Optionally, system 10 also comprises a display 60, allowing measurement data and calculated scores to be communicated to a user. This display 60 in one embodiment is an LCD screen, in other embodiments any other suitable known means of viewing is used. The display allows an operator to enter and evaluate the scores of a test subject, or a number of test subjects. As described below, the results that are shown on display 60 can also be indicative of the score for a complete installation, or multiple installations.

[030] Optionally, system 10 comprises transmission means 65, allowing measurement data and data stored in memory 30 to be transmitted to a remote server for further storage or processing. In one embodiment, the system 10 further comprises receiving means 66, which can be used to update the memory with historical data, or to change the calculations made by the processor 20.

[031] In use, measurement tools 40, 50 are used to perform a series of measurements on the skin of a user's hands. The specific measurements depend on the specific measuring tools 40, 90 employed.

Processor 20 calculates a user score from the data provided by measuring instrument 40, 50. In one embodiment, the component data for each measuring instrument 40, 50 is given equal weighting to provide a total result indicative of general skin health of the user's hands. In an alternative embodiment, the data for each measuring instrument 40, 50 are weighted differently so that the user score is indicative of the severity of a particular condition or combination of skin conditions. The user's score was written in memory 30.

[032] The scoring process is described in greater detail below with reference to Figure

two.

[033] Thus, the system in Figure 1 allows an automated and systematic collection of the data necessary to carry out the pre-clinical evaluation of the skin condition. When carrying out the evaluation using the described system, the user's bias is substantially reduced since a weighted score is calculated in a systematic way using equipment that produces accurate and reliable data.

These data also allow the collected data to be validly compared with previous and later data collected using the same system and equipment, improving the ability to recognize historical and predicted trends.

[034] Another advantage is that the system allows for large-scale grouping of data. Although individual users are assigned a score to provide an indication of their risk of future development of one or more clinical skin conditions, the score can be applied to a group of users within a facility or the entire facility itself. For example, in a factory setting, it can be useful to identify users according to their work environment, such as office-based workers who may be less likely to suffer from certain conditions than workers on the factory floor.

[035] In addition, how scores are generated and saved can be viewed and observed to identify trends over time, or by comparing different installations, on a user-to-user basis when the entire workforce. In addition, this visualization can allow a skin care professional to identify best practices and monitor the impact of such best practices over time.

[036] The scores can advantageously be compared to the previously recorded scores stored in memory 30. Thus, trends for users, user groups and facilities can be easily viewed over time. In addition, as scores are weighted and calculated consistently, scores between different users, user groups and facilities can be compared allowing comparison between a predetermined target group and the measured group in order to determine and identify best practices.

[037] Figure 2 shows a flow chart of the steps taken to calculate a representative risk score for a user of future development of one or more clinical skin conditions.

[038] The process starts at step S100. The system is initialized and measurement tools 40, 50 are activated and used to measure the physical attributes of a user's skin, including erythema, flaking, wheal density, vesicle density, infiltration, fissure, the hydration level of the surface , the skin barrier function and the loss of transepidermal water. In a preferred mode, the attributes of an individual's skin are measured in his hands, thus providing a measure of the skin of the hands. In additional modalities, other measures of an individual's skin attributes are measured in locations other than the individual's hands.

[039] This data is then sent to processor 20 and, optionally, memory 30. The methods by which each attribute is measured are known in the art.

For example, a preliminary visual assessment can be performed covering six morphological signs of skin damage in eight different areas on the hands. The eight areas consist of the front of the fingers, the palms, the back of the hands and the back of the fingers on both the left and right hands. If a morphological signal is observed in one of the eight areas, it scores as one. If the signal is present in two areas, it scores as two, and so on, up to a maximum of three. When scoring cracks, a small flat fissure scores 1 and a deep fissure scores 3.

Anything these scores 2. A user can thus score between 0 and 18 in this particular measurement, with 0 indicating good skin health.

[040] In addition, the measurement can be performed using one or more of a temperature sensor, humidity sensor, parallel and transverse polarized light chamber and a chromatic absorption sensor. For example, erythema is measured using a Mexameter, which uses the reflection of light to give L-A-B color values. Five point measurements are taken on the back of both the left and the right hand, The Mexmetro then emits the average value of erythema in both hands, between 0 and 100.

[041] The moisture content is measured using a Corneometer that is based on the capacitance method. The probe is placed in contact with a flat, hairless surface of the skin. This results in occlusion, since water is accumulated under the probe head, unable to evaporate. Again, five point measurements are taken on the back of each of the user / tester's hands, obtaining a score between 0 and 60.

[042] Transepidermal water loss is measured using a Tewameter. Tewameter operates on the principle of open chamber measurement, whereby water evaporates through the chamber and the resulting density gradient is measured by two pairs of sensors. Here, the Tewameter probe is held in the area of the skin between the thumb and the index finger for thirty seconds before generating a value between 0 and 20, 0 indicating the healthiest skin.

[043] Visioscope is used to assess squamousness. Scaling is indicated by the number and thickness of skin flakes collected by a strip of corneofix tape. The tape is pressed onto a user's skin before being held onto the Visioscope camera. The Visioscope then produces a value between 0-100% of scaliness.

[044] In step S110, processor 20 uses the data and receives the data from each of the measurement tools 40, 50 and calculates a first score characterizing each physical attribute measured by the measurement tools. Optionally, this first score is the output to memory 30.

[045] As the scores are measured using the different range, (for example, 0 to 100, 0 to 18 etc.) in one mode the scores for each test are sized so that they are all measured over the same range, for example, 0 to 10. Such scaling of scores for the same range can make calculating the single score easier.

[046] In step S120, processor 20 combines each of the first scores into a user score, providing a concise, simple and actionable scaling output indicative of the user's overall skin health. In one embodiment, each value transmitted by each measurement device or method is normalized as a percentage of the total output, and the resulting values are weighted in order to provide an overall skin health indicator. In one mode, where scores are staggered so that they are measured over the same range, a total score can be recorded by adding the scores for each test. In other embodiments, measurement devices or methods are identified as being most useful in diagnosing a particular skin condition or precondition of interest. In such modalities, therefore, these methods are more heavily weighted in calculating the user's score, which in turn provides a measure of the user's particular risk of having or developing the condition of interest. Thus, the score would generate a more reliable preclinical indication that a person may suffer from a particular condition.

[047] The user's score is then saved in memory 30.

[048] Steps S100-S120 are then repeated for a number of different users, producing a set of individual user scores for each user's hands. In one embodiment, these users form a statistically significant sample group from a larger population. In one embodiment, this larger population is the staff of a particular institution or facility in particular.

[049] In step S130, this set of user scores is combined into a single score representative of the sample group, and the largest population. Thus, for example, two hundred individuals can be measured in a factory with two thousand workers, producing a score applicable to the entire facility. Alternatively, users can be subdivided into interest categories, for example, age, job, etc., and scores are assigned to each category. This installation or category score is saved in memory 30.

[050] In step S140, the processor compares values from the first scores, user scores and facility scores with those stored in memory to identify trends at all levels of data (for example, individual users, categories of users / groups and entire facilities) and avoid skin diseases / injuries by addressing latent risks at an early stage. These trends can be used to predict future values for a user, installation score group. If a predicted score exceeds a predetermined threshold, the system can cause an output, for example, through the display 60 or transmission means in order to take immediate preventive action at the individual level or the entire facility, as needed. In one embodiment, the scores issued by system 10 are transmitted to a remote server and displayed via an assessable internet panel, thus allowing administrators to remotely observe, evaluate and address the scores received by the team member and the facilities. This further facilitates the comparison and comparative analysis of multiple individuals and facilities, which can be tracked and managed over time.

[051] As such, the present invention provides a system that allows an early preclinical determination of a skin condition through the use of various tests, which are then scored. The total score gives a preclinical indication that a user may suffer from, or is showing signs of a skin condition, for example, contact dermatitis.

Advantageously, said pre-determination

clinic can be performed by a non-medical practitioner, as it only requires the administration of different hand tests, rather than analyzing the results.

Claims (18)

1. System configured to quantify risk associated with preclinical indicators of one or more clinical skin conditions based on the hands, the system characterized by the fact that it comprises a plurality of measurement tools in connection with a processor, each of the plurality of the measuring means configured to measure a skin property of an individual's hands, said property related to skin health, where each of the plurality of measurement tools is configured to provide a first characteristic score of skin health of the individual's hands, and where the processor is configured to calculate a second score based on the first combined scores from each of a plurality of measurement tools, the second score representing the individual's risk of future development of a or more clinical skin conditions. 2. System according to claim 1, characterized by the fact that the measuring tools measure at least two of erythema, scaling, wheal density, vesicle density, cracks, the hydration level of the surface, the function barrier and loss of transepidermal water from an individual's hand. 3. System, according to any of the preceding claims, characterized by the fact that the processor gives one or more of the first scores a different weight in the calculation of the second score. 4. System, according to any one of the preceding claims, characterized by the fact that it also comprises a plurality of individuals, in which the processor combines the second score of each individual into a third score representative of the plurality of individuals. 5. System, according to claim 4, characterized by the fact that the plurality of individuals is representative of a larger population in such a way that the third score can be mapped to the larger population. 6. System, according to claim 5, characterized by the fact that the largest population is the total labor force in the private workplace. 7. System according to any one of the preceding claims, characterized by the fact that the plurality of measurement tools comprises one or more of a temperature sensor, humidity sensor, parallel and cross polarized light chamber and a chromatic absorption sensor . 8. System, according to any one of the previous claims, characterized by the fact that it also comprises a memory in communication with the processor, in which the memory is configured to store the data from multiple measurement sections, and in which the memory is further configured to provide data from previous measurement sessions to the processor, and the processor is configured to track changes in a score over time. 9. System, according to claim 8, characterized by the fact that the processor is still configured to recognize a historical trend in the measurement data and predict future values of a score. 10. System, according to any of the preceding claims, characterized by the fact that it also comprises means of indication to alert a user that a calculated score exceeds a predetermined limit. 11. Method for quantifying the health of the skin of the hands, the method characterized by the fact that it comprises the steps of assessing the health of the skin of the hands of an individual, using a plurality of measurement tools, each of the plurality of measurement means configured to measure a skin property of an individual's hand, said property related to skin health; where the plurality of measurement tools is further configured to provide a first score characteristic of the individual's hand skin health, and calculation of a second score based on the combined data from the plurality of measurement tools, the second score representing an overall skin health score in the individual's hands. 12. Method, according to claim 11, characterized by the fact that it further comprises the step of assessing the skin condition of a plurality of individuals; and calculating a third score representative of the plurality of individuals based on each individual's second score. 13. Method, according to claim 12, characterized by the fact that the plurality of individuals is representative of a larger population, which also comprises the step of mapping the third score to the larger population. 14. Method, according to claim 13, characterized by the fact that the largest population is the total workforce in the particular workplace. 15. Method, according to any of claims 11 to 14, characterized by the fact that it also comprises the steps of repeating the calculation evaluation steps and over time as well as for tracking changes in at least one of the first, second or third scores. 16. Method, according to claim 15, characterized by the fact that it also comprises the step of recognizing a trend in historical measurement data and predicting future values of at least one of the first, second and third scores. 17. Method according to any of claims 11 to 16, characterized by the fact that it further comprises the step of alerting a user that a calculated score exceeds a predetermined limit. 18. Method according to any of claims 11 to 17, characterized in that the properties measured by the measuring tools are at least two of erythema, scaling, papule density, vesicle density, infiltration, fissure, level surface hydration, skin barrier function and transepidermal water loss.